RegWardenFDA facility compliance records
Company

NOVA BIOMEDICAL CORP.

7 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2013: 3 recalls; 2017: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2026: 1 recalls3’13’14’15’161’17’18’19’20’21’221’231’24’251’26
  • Recalls (7)

Registered facilities (4)

Recalls & enforcement

  • Class IOngoing2026-07-29
    A software synchronization/timing issue in the barcode scanning and patient data processing component that causes the device to intermittently retain a previously scanned barcode including patient identification (ID) barcodes and quality control (QC) solution ID barcodes when…
  • Class IOngoing2024-11-20
    A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone patient test results to a healthcare institution's data management system (DMS) at healthcare sites using WiFi if a user navigates to the Review Results screen while the meter is in …
  • Class IIOngoing2023-09-18
    Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control …
  • Class IITerminated2017-06-19
    Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.
  • Class IITerminated2013-10-10
    Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
  • Class ITerminated2013-07-15
    Reports of false abnormally high glucose readings from test strips
  • Class IITerminated2013-02-25
    Glucose test strips reports no result message when tested

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “NOVA BIOMEDICAL CORP. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1219029-nova-biomedical-corp/

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